RecruitingNot ApplicableNCT05366699

LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy

A Randomized Clinical Trial of the LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy


Sponsor

Stanford University

Enrollment

80 participants

Start Date

Sep 10, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Lymphedema is a chronic, progressive, and debilitating condition that occurs with disruption or obstruction of the lymphatic system, which commonly occurs a result of breast cancer therapy. The purpose of this study is to determine if the use of a low risk lymphatic reconstruction procedure at the time of axillary lymph node dissection will reduce the risk of developing lymphedema. Additionally, to determine if this procedure improves objective outcomes of lymphedema and patient quality of life


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a surgical procedure called LYMPHA (Lymphatic Microsurgical Preventive Healing Approach) to prevent lymphedema (arm swelling from blocked lymph vessels) in breast cancer patients who need lymph node removal from the armpit. The procedure reconnects lymphatic vessels during breast cancer surgery to reduce the risk of lymphedema developing later. **You may be eligible if...** - You are 18–75 years old - You are having breast cancer surgery that includes removal of lymph nodes from the armpit - You do not currently have lymphedema in the arm - You have no distant cancer spread detected before surgery **You may NOT be eligible if...** - You already have lymphedema in the affected arm - You have had radiation to the armpit area before this surgery - You are allergic to pig collagen or ICG dye (used in the procedure) - You are pregnant or nursing - You have severe kidney or liver disease - Your life expectancy is less than 2 years - You have a condition that would cause arm swelling for other reasons Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREaxillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA)

lymphatic reconstruction where the cut lymphatic vessels are reconstructed by anastamosing to the veins

PROCEDUREAxillary lymphadenetomy alone

oncologic axillary lymphadenectomy

PROCEDUREaxillary lymphadenectomy with soft tissue reinforcement

axillary lymphadenectomy with soft tissue reinforcement(STR)


Locations(1)

Stanford Cancer Institute

San Francisco, California, United States

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NCT05366699


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